MHRA to pick up on-site inspections by end of March
The MHRA announces its return to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.
What has to be considered?
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The authority will pre-notifiy an on-site inspection within a minimum of 14 days in advance.
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There will be a reasonable request for a minimized number of personnel on site, only.
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Social distancing will be given a top priority and a necessary remote standby of personnel will be discussed beforehand.
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Provision of documents via electronic means is preferred once on site, as well as in advance of physical linspection
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A physical inspection backroom is not expected but rather a workspace for inspectors allowing them social distancing.
A detailed guidance for industry on the MHRA’s expectations is provided here.
Source:
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